Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Mean number cigarettes smoked per day
研究概览
简要总结
The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.
详细描述
The primary objectives of this study are to compare the effectiveness of two types of behavioral interventions, when combined with varenicline medication, in promoting tobacco cessation among treatment-seeking adults and to elucidate the underlying mechanisms. The secondary objective of this study is to examine sex differences.
Investigators will recruit from two primary sources: 1) community-based recruitment strategies including web and social media ads, lay community members to recruit, and local communication channels; 2) investigators will invite referred patients to the outpatient Tobacco Treatment Service (TTS) at Yale-New Haven Hospital.
All participants will be assigned to one of two behavioral interventions. Both groups will receive treatment with varenicline and attend weekly individual counseling sessions (standard care or cognitive behavioral therapy for insomnia) and wear research-grade sleep actiwatches for passive sleep monitoring.
Participants will have a total of five expected research visits with a scheduled target quit date for Week 4. Participants will undergo MRI at baseline and at Week 4, and attend follow-ups at week 8, 12, and 26.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English literate
- •report heavy tobacco use (including nicotine e-cigarettes) for >6 months
- •meet biochemical cut off for recent cigarette smoking or e-cigarette use
- •optimal body mass index
排除标准
- •currently enrolled in other treatments
- •neuropsychiatric exclusions that could interfere with study participation, increase risk of adverse events, and/or induce deficient sleep
- •medical contraindications for fMRI, varenicline, and/or behavioral treatment
- •factors that cause deficient sleep and for which behavioral treatment has less benefit
- •women who are pregnant or nursing
研究组 & 干预措施
Experimental health intervention
Experimental health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks
干预措施: Experimental health intervention (Behavioral)
Control health intervention
Control health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks
干预措施: Varenicline (Drug)
Experimental health intervention
Experimental health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks
干预措施: Varenicline (Drug)
结局指标
主要结局
Mean number cigarettes smoked per day
时间窗: Baseline, week 4, 8, 12, and 26
Mean number cigarettes smoked per day assessed by Time Line Follow Back method
Smoking status
时间窗: Baseline
Assess expired breath carbon monoxide (CO) at baseline. CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO \<5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels).
Quit status
时间窗: Week 4, 8, 12, and 26
To inquire whether participants have refrained from tobacco use at each visit following their quit date. The quit status will also be verified by assessing expired breath carbon monoxide (CO). CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO \<5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels)
Days to smoking relapse
时间窗: Week 4, 8, 12, and 26
Days of resuming smoking since Week 4 schedule quit date as assessed by the Time Line Follow-back
次要结局
- Change in PROMIS Sleep Disturbance(Baseline, week 4, 8, 12, and 26)
- Change in PROMIS Sleep-Related Impairment(Baseline, week 4, 8, 12, and 26)
- Change in Insomnia Severity Index(Baseline, week 4, 8, 12, and 26)